This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.
Age ≥ 18 years old
Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma)
Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm.
Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm.
FL grade 3B or transformed FL
Patients receiving any other investigational agents
Patients with known central nervous system involvement of lymphoma
History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included
Single group
Rituximab
Biological/VaccineGiven IV
Tafasitamab
Biological/VaccineGiven IV
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Computed Tomography
Procedure/SurgeryUndergo CT scan
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Survey Administration
Other interventionAncillary studies
Complete remission at the best response
Assessed by positron emission tomography (PET)/computed tomography (CT) and diagnostic CT scans based on Lugano criteria. Will report the number of complete response (CR) at the best response within one year of starting study treatment and the estimated CR rate with 95% exact binomial confidence interval (CI).
Incidence of adverse events (AEs)
Defined as the incidence and severity of each AE graded based on Common Terminology Criteria for Adverse Events, among patients who receive at least one dose of tafasitamab. Will report the count, percentage, and 95% exact binomial CI.
Overall response at the best response
Among response evaluable patients, the overall response including complete remission and partial response at the best response assessed by PET/CT and diagnostic CT scans based on Lugano criteria.
Complete remission
Defined as complete remission after cycle 6 of rituximab and tafasitamab, assessed by PET/CT and diagnostic CT scans, based on Lugano criteria.
Progression free survival (PFS)
Will apply Kaplan-Meier method to estimate the survival rate. Will report 12-month and 24-month PFS rates with 95% CI.
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University of Washington
Lead sponsor
Incyte Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
